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The National Health Service (General Medical Services Contracts) (Wales) Regulations 2004

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PART 1GENERAL

Citation, commencement and application

1.—(1) These Regulations may be cited as the National Health Service (General Medical Services Contracts) (Wales) Regulations 2004 and shall come into force on 1st March 2004.

(2) These Regulations apply in relation to Wales only.

Interpretation

2.—(1) In these Regulations —

the Act” means the National Health Service Act 1977;

“the 1990 Act” means the National Health Service and Community Care Act 1990;

“the 2003 Order” means the General and Specialist Medical Practice (Education, Training and Qualifications) Order 2003(1);

Abolition of the Tribunal Regulations” means the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 2001(2);

Abolition of the Tribunal (Wales) Regulations” means the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 2002(3);

“additional services” means one or more of —

(a)

cervical screening services,

(b)

contraceptive services,

(c)

vaccinations and immunisations,

(d)

childhood vaccinations and immunisations,

(e)

child health surveillance services,

(f)

maternity medical services, and

(g)

minor surgery;

“adjudicator” means the Assembly or a person or persons appointed by the Assembly under section 4(5) of the 1990 Act or paragraph 101(5) of Schedule 6;

“appliance” means an appliance which is included in a list for the time being approved by the Assembly for the purposes of section 41 of the Act;

“approved medical practice” shall be construed in accordance with section 11(4) of the Medical Act 1983(4);

“Assembly” means the National Assembly for Wales;

“assessment panel” means a committee or sub-committee of a Local Health Board (other than the Local Health Board which is a party to the contract in question) appointed to exercise functions under paragraphs 31 and 35 of Schedule 6;

“bank holiday” means any day that is specified or proclaimed as a Bank holiday pursuant to section 1 of the Banking and Financial Dealings Act 1971(5);

“batch issue” means a form provided by a Local Health Board and issued by a prescriber at the same time as a repeatable prescription to enable a chemist to receive payment for the provision of repeat dispensing services which is in the format specified in Part 2 of Schedule 1, and which —

(a)

is generated by a computer and not signed by a prescriber,

(b)

relates to a particular repeatable prescription and contains the same dates as that prescription,

(c)

is issued as one of a sequence of forms, the number of which is equal to the number of occasions on which the drugs, medicines or appliances ordered on the repeatable prescription may be provided, and

(d)

specifies a number denoting its place in the sequence referred to in paragraph (c);

CCT” means Certificate of Completion of Training awarded under article 8 of the 2003 Order, including any such certificate awarded in pursuance of the competent authority functions of the Postgraduate Medical Education and Training Board specified in article 20(3)(a) of that Order;

“cervical screening services” means the services described in paragraph 2(2) of Schedule 2;

“charity trustee” means one of the persons having the general control and management of a charity;

“chemist” means —

(a)

a registered pharmacist,

(b)

a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968(6), or

(c)

a supplier of appliances,

who is included in the list of a Local Health Board or a Primary Care Trust under section 42 of the Act, or who provides local pharmaceutical services in accordance with LPS arrangements;

CHC” means a Community Health Council retained or established under section 20A of the Act(7);

“child” means a person who has not attained the age of 16 years;

“child health surveillance services” means the services described in paragraph 6(2) of Schedule 2;

“childhood vaccinations and immunisations” means the services described in paragraph 5(2) of Schedule 2;

“closed”, in relation to the contractor’s list of patients, means closed to applications for inclusion in the list of patients other than from immediate family members of registered patients;

“contraceptive services” means the services described in paragraph 3(2) of Schedule 2;

“contract” means, except where the context otherwise requires, a general medical services contract under section 28Q of the Act;

“contractor’s list of patients” means the list prepared and maintained by the Local Health Board under paragraph 14 of Schedule 6;

“core hours” means the period beginning at 8am and ending at 6.30pm on any day from Monday to Friday except Good Friday, Christmas Day or bank holidays;

“dispensing services” means the provision of drugs, medicines or appliances that may be provided as pharmaceutical services by a medical practitioner in accordance with arrangements made under regulation 20 of the Pharmaceutical Regulations;(8)

“Drug Tariff” has the same meaning as in regulation 18 of the Pharmaceutical Regulations;

“enhanced services” are —

(a)

services other than essential services, additional services or out of hours services, or

(b)

essential services, additional services or out of hours services or an element of such a service that a contractor agrees under the contract to provide in accordance with specifications set out in a plan, which requires of the contractor an enhanced level of service provision compared to that which it needs generally to provide in relation to that service or element of service;

“essential services” means the services required to be provided in accordance with regulation 15;

FHSAA” means the Family Health Service Appeal Authority constituted under section 49S of the Act(9);

“general medical practitioner means —

(a)

from the coming into force of article 10 of the 2003 Order, a medical practitioner whose name is included in the General Practitioner Register otherwise than by virtue of paragraph 1(d) of Schedule 6 of that Order, and

(b)

until the coming into force of that article, a medical practitioner who is either —

(i)

until the coming into force of paragraph 22 of Schedule 8 to the 2003 Order, suitably experienced within the meaning of section 31(2) of the Act, section 21 of the National Health Service (Scotland) Act 1978(10) or Article 8(2) of the Health and Personal Social Services (Northern Ireland) Order 1978(11); or

(ii)

upon the coming into force of paragraph 22 of Schedule 8 to the 2003 Order, an eligible general practitioner pursuant to that paragraph other than by virtue of having an acquired right under paragraph 1(d) of Schedule 6 to the 2003 Order;

“General Practitioner Register” means the register kept by the General Medical Council under article 10 of the 2003 Order;

“global sum” has the same meaning as in the GMS Statement of Financial Entitlements;

“GMS Statement of Financial Entitlements” means the directions given by the Assembly under section 28T of the Act(12) on 1st April 2004;

GP Registrar”—

(a)

until the coming into force of article 5 of the 2003 Order, means a medical practitioner who is being trained in general practice by a medical practitioner who—

(i)

has been approved for that purpose by the Joint Committee on Postgraduate Training for General Practice under regulation 7 of the National Health Service (Vocational Training for General Medical Practice) Regulations 1997(13), and

(ii)

performs primary medical services, and

(b)

from the coming into force of that article, means a medical practitioner who is being trained in general practice by a GP Trainer whether as part of training leading to the award of a CCT or otherwise;

“GP Trainer” means a general medical practitioner who is ?

(a)

until the coming into force of article 4(5)(d) of the 2003 Order, approved as a GP Trainer by the Joint Committee on Postgraduate Training for General Practice under regulation 7 of the National Health Service (Vocational Training for General Medical Practice) Regulations 1997; or

(b)

from the coming into force of that article, approved by the Postgraduate Medical Education and Training Board under article 4(5)(d) of the 2003 Order for the purposes of providing training to a GP Registrar under article 5(1)(c)(i);

“Health and Social Services Board” means a Health and Social Services Board established under the Health and Personal Social Services (Northern Ireland) Order 1972(14);

“Health and Social Services Trust” means a Health and Social Services Trust established under Article 10(1) of the Health and Personal Social Services (Northern Ireland) Order 1991(15);

“Health Board” means a Health Board established under section 2 of the National Health Service ( Scotland) Act 1978(16);

“health care professional” has the same meaning as in section 28M of the Act and “health care profession” shall be construed accordingly;

“health service body” has, unless the context otherwise requires, the meaning given to it in section 4(2) of the 1990 Act;

“immediate family member” means —

(a)

a spouse,

(b)

a person (whether or not of the opposite sex) whose relationship with the registered patient has the characteristics of the relationship between husband and wife,

(c)

a parent or step-parent,

(d)

a son,

(e)

a daughter,

(f)

a child of whom the registered patient is —

(i)

the guardian, or

(ii)

the carer duly authorised by a local authority to whose care the child has been committed under the Children Act 1989(17), or

(g)

a grandparent;

“independent nurse prescriber” means a person—

(a)

who is either engaged or employed by the contractor or is a party to the contract,

(b)

who is registered in the Nursing and Midwifery Register, and

(c)

in respect of whom an annotation signifying that he or she is qualified to order drugs, medicines and appliances from—

(i)

the Nurse Prescribers' Formulary for District Nurses and Health Visitors in Part XVIIB(i) of the Drug Tariff, or

(ii)

the Nurse Prescribers' Extended Formulary in Part XVIIB(ii) of the Drug Tariff,

is also included in that register;

“licensing authority” shall be construed in accordance with section 6(3) of the Medicines Act 1968(18);

“licensing body” means any body that licenses or regulates any profession;

“limited partnership” means a partnership registered in accordance with section 5 of the Limited Partnerships Act 1907(19);

“Local Health Board” means, unless the context otherwise requires, the Local Health Board which is a party, or prospective party, to the contract(20);

“Local Medical Committee” means a committee recognised under section 45A of the Act;

“local pharmaceutical services” has the same meaning as in regulation 2 of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) Regulation 2002(21).

“maternity medical services” means the services described in paragraph 7(1) of Schedule 2;

“medical card” means a card issued by a Local Health Board, Primary Care Trust, Health Authority, Health Board or Health and Social Services Board to a person for the purpose of enabling him to obtain, or establishing his title to receive, primary medical services;

“medical officer” means a medical practitioner who is —

(a)

employed or engaged by the Department for Work and Pensions, or

(b)

provided by an organisation in pursuance of a contract entered into with the Secretary of State for Work and Pensions;

“medical performers list” means a list of medical practitioners prepared in accordance with regulations made under section 28X of the Act(22);

“Medical Register” means the registers kept under section 2 of the Medical Act 1983(23);

“minor surgery” means the services described in paragraph 8(2) of Schedule 2;

NCAA” means the National Clinical Assessment Authority established as a Special Health Authority under section 11 of the Act;

“national disqualification” means —

(a)

a decision made by the FHSAA under section 49N of the Act,

(b)

a decision under provisions in force in Scotland or Northern Ireland corresponding to section 49N of the Act, or

(c)

a decision by the NHS Tribunal which is treated as a national disqualification by the FHSAA by virtue of regulation 6(4)(b) of the Abolition of the Tribunal Regulations or regulation 6(4)(b) of the Abolition of the Tribunal (Wales) Regulations;

“NHS contract” has the meaning assigned to it in section 4 of the 1990 Act;

“the NHS dispute resolution procedure” means the procedure for resolution of disputes specified —

(a)

in paragraphs 99 and 100 of Schedule 6; or

(b)

in a case to which paragraph 36 of Schedule 6 applies, in that paragraph.

“the NHS Tribunal” means the Tribunal constituted under section 46 of the Act(24) for England and Wales, and which, except for prescribed cases, had effect in relation to England only until 14th December 2001 and in relation to Wales only until 26th August 2002(25);

“normal hours” means those days and hours on which and the times at which services under the contract are normally made available and may be different for different services;

“Nursing and Midwifery Register” means the register maintained by the Nursing and Midwifery Council under the Nursing and Midwifery Order 2001(26);

“open”, in relation to a contractor’s list of patients, means open to applications from patients in accordance with paragraph 15 of Schedule 6;

“out of hours period” means —

(a)

the period beginning at 6.30pm on any day from Monday to Thursday and ending at 8am on the following day;

(b)

the period between 6.30pm on Friday and 8am on the following Monday, and

(c)

Good Friday, Christmas Day and bank holidays,

and “part” of an out of hours period means any part of any one or more of periods described in paragraphs (a) to (c);

“out of hours services” means services required to be provided in all or part of the out of hours period which —

(a)

would be essential services if provided in core hours, and

(b)

are included in the contract as additional services funded under the global sum;

“parent” includes, in relation to any child, any adult who, in the opinion of the contractor, is for the time being discharging in respect of that child the obligations normally attaching to a parent in respect of his or her child;

“patient” means —

(a)

a registered patient,

(b)

a temporary resident,

(c)

persons to whom the contractor is required to provide immediately necessary treatment under regulation 15(6) or (8) respectively,

(d)

any other person to whom the contractor has agreed to provide services under the contract,

(e)

any person for whom the contractor is responsible under regulation 31, and

(f)

any person for whom the contractor is responsible under arrangements made with another contractor in accordance with Schedule 7;

“Pharmaceutical Regulations” means the National Health Service (Pharmaceutical Services) Regulations 1992(27);

“pilot scheme” means an agreement made under Part 1 of the National Health Service (Primary Care) Act 1997(28);

“the POM Order” means the Prescription Only Medicines (Human Use) Order 1997(29);

“practice” means the business operated by the contractor for the purpose of delivering services under the contract;

“practice area” means the area referred to in regulation 18(1)(d);

“practice leaflet” means a leaflet drawn up in accordance with paragraph 75 of Schedule 6;

“practice premises” means an address specified in the contract as one at which services are to be provided under the contract;

“prescriber” means —

(a)

a medical practitioner,

(b)

an independent nurse prescriber, and

(c)

a supplementary prescriber,

who is either engaged or employed by the contractor or is a party to the contract;

“prescription form” means a form provided by the Local Health Board and issued by a prescriber to enable a person to obtain pharmaceutical services or local pharmaceutical services and does not include a repeatable prescription;

“prescription only medicine” means a medicine referred to in article 3 of the POM Order (medicinal products on prescription only);

“primary care list” means —

(a)

a list of persons performing primary medical or dental services prepared in accordance with regulations made under section 28X of the Act(30),

(b)

a list of persons undertaking to provide general medical services, general dental services, general ophthalmic services or, as the case may be, pharmaceutical services prepared in accordance with regulations made under sections 29, 36, 39, 42 or 43 of the Act,

(c)

a list of persons approved for the purposes of assisting in the provision of any services mentioned in paragraph (b) prepared in accordance with regulations made under section 43D of the Act(31),

(d)

a services list referred to in section 8ZA of the National Health Service (Primary Care) Act 1997(32),

(e)

a list corresponding to a services list prepared by virtue of regulations made under section 41 of the Health and Social Care Act 2001(33), or

(f)

a list corresponding to any of the above lists in Scotland or Northern Ireland;

“Primary Care Trust” means, a Primary Care Trust established under section 16A of the Act;

“primary carer” means, in relation to an adult, the adult or organisation primarily caring for that adult;

“registered patient” means —

(a)

a person who is recorded by the Local Health Board as being on the contractor’s list of patients, or

(b)

a person whom the contractor has accepted for inclusion on its list of patients, whether or not notification of that acceptance has been received by the Local Health Board and who has not been notified by the Local Health Board as having ceased to be on that list;

“relevant register” means —

(a)

in relation to a nurse, the Nursing and Midwifery Register, and

(b)

in relation to a pharmacist, the register maintained in pursuance of section 2(1) of the Pharmacy Act 1954(34) or the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976(35);

“repeat dispensing services” means pharmaceutical services or local pharmaceutical services which involve the provision of drugs, medicines or appliances by a chemist in accordance with a repeatable prescription;

“repeatable prescribing services” means services which involve the prescribing of drugs, medicines or appliances on a repeatable prescription;

“repeatable prescription” means a prescription contained in a form provided by a Local Health Board and issued by a prescriber to enable a person to obtain pharmaceutical services or local pharmaceutical services, which is in the format specified in Part 1 of Schedule 1 and which —

(a)

is generated by a computer but signed by a prescriber, and

(b)

indicates that the drugs, medicines or appliances ordered on that form may be provided more than once and specifies the number of occasions on which they may be provided;

“restricted availability appliance” means an appliance which is approved for particular categories of persons or particular purposes only;

“Scheduled drug” means —

(a)

a drug, medicine or other substance specified in any directions given by the Assembly under section 28U of the Act(36) as being a drug, medicine or other substance which may not be ordered for patients in the provision of medical services under the contract, or

(b)

except where the conditions in paragraph 42(2) of Schedule 6 are satisfied, a drug, medicine or other substance which is specified in any directions given by the Assembly under section 28U of the Act as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes;

“section 28C provider” means a person who is providing services under a pilot scheme or in accordance with section 28C arrangements;

“supplementary prescriber” means a person —

(a)

who is either engaged or employed by the contractor or is a party to the contract,

(b)

whose name is registered in —

(i)

the Nursing and Midwifery Register,

(ii)

the Register of Pharmaceutical Chemists maintained in pursuance of section 2(1) of the Pharmacy Act 1954, or

(iii)

the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976, and

(c)

and against whose name is recorded in the relevant register an annotation signifying that he or she is qualified to order drugs medicines and appliances as a supplementary prescriber;

“temporary resident” means a person accepted by the contractor as a temporary resident under paragraph 16 of Schedule 6 and for whom the contractor’s responsibility has not been terminated in accordance with that paragraph;

“walk-in centre” means a centre at which information and treatment for minor conditions is provided to the public under arrangements made by or on behalf of the Assembly;

“working day” means any day apart from Saturday, Sunday, Christmas Day, Good Friday or a bank holiday;

“writing”, except in paragraph 102(1) of Schedule 6 and unless the context otherwise requires, includes electronic mail and “written” shall be construed accordingly.

(2) In these Regulations, the use of the term “it” in relation to the contractor shall be deemed to include a reference to a contractor that is an individual medical practitioner or two or more individuals practising in partnership and related expressions shall be construed accordingly.

(1)

S.I. 2003/1250.

(2)

S.I. 2001/3744 amended by S.I. 2002/2469.

(3)

S.I. 2002/1920.

(4)

1983 c. 54; section 11(4) was amended by the National Health Service (Primary Care) Act 1997 (c. 46), section 35(4) and Schedule 2, paragraph 61(2).

(6)

1968 c. 67; section 69 was amended by the Statute Law (Repeals) Act 1993 (c. 50) and the Pharmacists (Fitness to Practise) Act 1997 (c. 19), Schedule 5, paragraph 5.

(7)

Section 20A was inserted by section 1 of the Health (Wales) Act 2003 (c. 4).

(8)

Section 49S was inserted into the Act by section 27(1) of the Health and Social Care Act 2001 (c. 15) (“the 2001 Act”).

(10)

S.I. 1978/1907 (N.I. 26)) or would have been so considered notwithstanding the repeal of the relevant provision.

(11)

Section 28T was inserted into the Act by section 175 of the 2003 Act.

(12)

S.I. 1997/2817 as amended by S.I, 1998/669.

(16)

Section 4(2) was amended by the Health Authorities Act 1995 (c. 17) Schedule 1, paragraph 68, the Health Act 1999 (c. 8), Schedule 4, paragraph 76(a) and Schedule 5, the National Health Service Reform and Health Care Professions Act 2002 (c. 17), Schedule 1, paragraph 40, and Schedule 5, paragraph 31.

(20)

Local Health Boards were established under section 16BA of the Act; SI 2003/148 (W.18)

(22)

Section 28X was inserted into the Act by section 179(1) of the 2003 Act.

(23)

1983 c. 54; section 2 was amended by S.I. 1996/1591 and 2002/3135.

(24)

Section 46 was revoked by the 2001 Act, section 67, Schedule 5, paragraphs 5 and Schedule 6, Part 1.

(25)

See S.I. 2001/3738, article 2(5) and (6)(b), which sets out the prescribed cases for England and S.I. 2002/1919, article 2(2) and (3)(b), which sets out the prescribed cases for Wales.

(26)

S.I. 2002/253.

(29)

S.I. 1997/1830 as amended by S.I 1997/2044, 1998/108, 1178 and 2081, 1999/1044 and 3463, 2000/1917, 2889 and 3231, 2001/2777, 2889 and 3942, 2002/549 and 2469 and 2003/696.

(30)

Section 28X was inserted into the Act by section 179(1) of the 2003 Act.

(31)

Section 43D was inserted into the Act by section 24 of the 2001 Act.

(32)

1997 c. 46. Section 8ZA was inserted into that Act by section 26(2) of the 2001 Act.

(36)

Section 28U was inserted into the Act by section 171 of the 2003 Act. The current directions are…

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